pregabalin

Generic: pregabalin

Labeler: ascend laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pregabalin
Generic Name pregabalin
Labeler ascend laboratories, llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

pregabalin 20 mg/mL

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-457
Product ID 67877-457_59a80208-5cc1-476c-a24b-296bc68e1e0d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207623
DEA Schedule cv
Listing Expiration 2026-12-31
Marketing Start 2019-07-21

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67877457
Hyphenated Format 67877-457

Supplemental Identifiers

RxCUI
898715
UPC
0367877457475
UNII
55JG375S6M

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name pregabalin (source: ndc)
Generic Name pregabalin (source: ndc)
Application Number ANDA207623 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (67877-457-47)
source: ndc

Packages (1)

67877-457-47 473 mL in 1 BOTTLE (67877-457-47)

Ingredients (1)

pregabalin (20 mg/mL)

Linked Drug Pages (1)

Pregabalin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "59a80208-5cc1-476c-a24b-296bc68e1e0d", "openfda": {"upc": ["0367877457475"], "unii": ["55JG375S6M"], "rxcui": ["898715"], "spl_set_id": ["1b731dd5-b000-4c38-bfc8-2505b076e316"], "manufacturer_name": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (67877-457-47)", "package_ndc": "67877-457-47", "marketing_start_date": "20190721"}], "brand_name": "Pregabalin", "product_id": "67877-457_59a80208-5cc1-476c-a24b-296bc68e1e0d", "dosage_form": "SOLUTION", "product_ndc": "67877-457", "dea_schedule": "CV", "generic_name": "Pregabalin", "labeler_name": "Ascend Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pregabalin", "active_ingredients": [{"name": "PREGABALIN", "strength": "20 mg/mL"}], "application_number": "ANDA207623", "marketing_category": "ANDA", "marketing_start_date": "20190721", "listing_expiration_date": "20261231"}